Benign Prostatic Hyperplasia and Transurethral Waterjet Ablation of the Prostate

In the United States, 8 million men older than 50 years old suffer from Benign Prostatic Hyperplasia (BPH), a histological diagnosis characterized by an increased number of epithelial and stromal cells in the prostate. It is common in men over the age of 40, and the incidence increases with age. In many cases BPH is asymptomatic; however, symptoms may occur with prostate enlargement and compression of the urethra leading to bothersome lower urinary tract symptoms (LUTS), including urinary symptoms such as hesitancy, weak stream, straining, prolonged voiding, storage symptoms, frequency, urgency, and nocturia. BPH can have a significant impact on the quality of life and can cause serious complications, such as infections, bleeding, calculus (renal/urinary stone) formation, urinary retention, and decline of renal function when untreated.

First line treatment for BPH generally consists of treatment with medications, such as alpha blockers (Alfuzosin, doxazosin, terazosin, tamsulosin, prazosin), PDE5 Inhibitors (finasteride/dutasteride). If treatment with medications is not successful, surgical options may then be considered. Transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) are the standard surgical treatments for BPH and are highly effective and provide improved outcomes in urinary functions. However, neither TURP, nor OSP are without considerable perioperative complication and morbidity. Recently, minimally invasive surgeries have emerged as alternatives for the resection of the prostate. One such surgery is Transurethral Waterjet Ablation which is a minimally invasive water based surgical therapy that combines image guidance and robotics to remove prostatic tissue. The system works by pumping high pressure saline (500 to 8,000 pounds per square) through a probe nozzle to cut and dissect tissue at predetermined system parameters.

Treatment

Treatment for BPH will be considered reasonable and necessary when performed once in patients with the following:

1. Indications (include all the following):
   1. Prostate volume of 30–150 cc by transrectal ultrasound
   2. Persistent moderate to severe symptoms despite maximal medical management including all the following:
      1. International Prostate Symptom Score (IPSS) ≥12
      2. Maximum urinary flow rate (Qmax) of ≤15 mL/s (voided volume greater than 125 cc)
      3. Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., Alpha Blocker, PDE5 Inhibitor, Finasteride/Dutasteride)
          
2. Only treatment using a Food and Drug Administration approved/cleared device will be considered reasonable and necessary

Limitations

The following are considered not reasonable and necessary:

1. Body mass index ≥ 42kg/m2
    
2. Known or suspected prostate cancer (based on National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection guidelines) or a prostate specific antigen (PSA) >10 ng/mL unless the patient has had a negative prostate biopsy within the last six  months
    
3. Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum
    
4. Active urinary tract or systemic infection
    
5. Treatment for chronic prostatitis
    
6. Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture
    
7. Damaged external urinary sphincter
    
8. Known allergy to device materials
    
9. Inability to safely stop anticoagulants or antiplatelet agents preoperatively

Note: Services performed for any given diagnosis must meet all the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations (NCDs), and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in the Local Coverage Determination (LCD). 

Documentation Requirements

1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
    
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service). 
    
3. The documentation must include the legible signature of the physician or nonphysician practitioner responsible for and providing the care to the patient.
    
4. The submitted medical record must support the use of the selected ICD-10-CM code(s).
    
5. The submitted CPT®/HCPCS code must describe the service performed.

It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Codes

CPT®/HCPCS Codes

• C2596 Probe, Image Guided, Robotic, Water-Jet Ablation
• 0421T Waterjet Prostate 

It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

The ICD-10-CM code that supports medical necessity and provide coverage for the (CPT®/HCPCS) codes 0421T and C2596 — N40.1,  Benign prostatic hyperplasia with lower urinary tract symptoms.

ICD-10-CM code(s) that do not Support Medical Necessity — n/a.

ICD-10-PCS code(s) — n/a.

Additional ICD-10 Information — N/A.

Bill Type Codes

Contractors may specify bill types to help providers identify those typically used to report this service. Absence of a bill type does not guarantee that the article does not apply to that bill type. Complete absence of all bill types indicates that coverage is not influenced by bill type and the article should be assumed to apply equally to all claims.

Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Resources

• Billing and Coding: Transurethral Waterjet Ablation of the Prostate
• Local Coverage Determination (LCD) L38549 Transurethral Waterjet Ablation of the Prostate